Intramural Program Announcement
and
Application Instructions
for theDepartment of Defense Defense Health Program
Congressionally Directed Medical Research Programs Defense Medical Research and Development Program
Joint Program Committee-1/Medical Simulation and Information
Sciences Research Program
Medical Decision Aids – Predictive Markers (SimMarkers)
SUBMISSION AND REVIEW DATES AND TIMES
• Pre-Application Deadline: 5:00 p.m. Eastern time (ET), July 29, 2015
• Invitation to Submit an Application: September 9, 2015
• Application Submission Deadline: 5:00 p.m. ET, November 18, 2015
• Peer Review: February 2016
TABLE OF CONTENTS
I. Funding Opportunity Description ... 3
A. Program Description ... 3
B. Award Information... 5
C. Eligibility Information ... 8
D. Funding ... 8
II. Submission Information ... 10
A. Pre-Application Submission Content ... 10
B. Full Application Submission Content ... 14
III. Application Review Information ... 23
A. Application Review and Selection Process... 23
B. Application Review Process ... 23
C. Application Review Dates ... 26
D. Notification of Application Review Results ... 26
IV. Administrative Actions ... 26
A. Rejection ... 26
B. Modification ... 26
C. Withdrawal ... 26
D. Withhold ... 27
V. Award Administration Information ... 27
A. Award Notice ... 27
B. Administrative Requirements ... 27
C. Reporting... 27
D. Award Transfers... 28
E. Site Visits ... 28
VI. Agency Contacts ... 28
A. CDMRP Help Desk... 28
VII. Application Submission Checklist ... 29
APPENDIX 1 Formatting Guidelines ... 30
APPENDIX 2 Administrative Information ... 31
APPENDIX 3 Regulatory Requirements ... 34
I. FUNDING OPPORTUNITY DESCRIPTION
BEFORE APPLYING, PLEASE NOTE: THIS PROGRAM ANNOUNCEMENT/FUNDING OPPORTUNITY IS INTENDED FOR INTRAMURAL INVESTIGATORS ONLY.
A separate announcement for extramural investigators is available at Grants.gov
(http://www.grants.gov) under the Funding Opportunity Number W81XWH-15-DMR DP-MSIS-SIMMARKERS.
• An intramural investigator is defined as a Department of Defense (DoD) military or civilian employee working within a DoD laboratory, DoD military treatment facility, or working in a DoD activity embedded within a civilian medical center.
• An extramural investigator is defined as all those not included in the definition of intramural investigators above. Submissions from extramural investigators to this Program Announcement/Funding Opportunity will be rejected. It is permissible, however, for an extramural investigator to be named as a collaborator in an application submitted by an intramural investigator. In such cases, the intramural organization will receive all funds and is responsible for executing all necessary contractual or assistance funding awards to collaborating partners through their agency’s procedures.
A. Program Description
Applications to the Fiscal Year 2016 (FY16) Joint Program Committee 1 (JPC-1) Medical Simulation and Information Science (MSIS) are being solicited for the Defense Health Agency, Research, Development, and Acquisition (DHA RDA) Directorate, by the U.S. Army Medical Research Acquisition Activity (USAMRAA). As directed by the Office of the Assistant Secretary of Defense for Health Affairs OASD(HA), the DHA RDA Directorate manages and executes the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. Through the US Army Medical Research and Materiel Command (USAMRMC), the Congressionally Directed Medical Research Programs (CDMRP) provides Defense Medical Research and Development Program (DMRDP) execution management support for DHP core research program areas, including JPC-1/MSIS. This program announcement and subsequent awards will be managed and executed by CDMRP with strategic oversight from JPC-1/MSIS.
The mission of the JPC-1/MSIS is to explore the implications of models and technology for medical education and for the provision, management, and support of health services in the military. The JPC-1/MSIS plans, coordinates, and oversees a responsive world-class, tri-service science and technology program.
Per guidance from DoD Instruction 5000.02, “Operation of the Defense Acquisition System,” dated January 7, 2015, the outcomes of the research will be used to support the solution assessments/material considerations for materiel development of a SimMarkers tool kit or assessment system. The government plans to use research outcomes in assessing critical technology elements and technology maturity, system integration risk, future manufacturing feasibility, and, where necessary, technology maturation and demonstration needs.
The JPC-1/MSIS Medical Readiness Initiative (MRI): Medical Decision Aids – Predictive Markers
The JPC-1/MSIS MRI focuses on research development of medical training methods,
technologies, systems, and competency assessment tools for the attainment and sustainment of military medical readiness. MRI also includes methodologies, techniques, and tools that will allow for ethical, accurate, and appropriate pre-intervention rehearsal with input of authorized and personalized medical information into simulation models. Evidence-based efforts with measurable outcomes and reliable assessments also fall under the Medical Readiness Initiative. The evolution of military medicine over the past 25 years has led to significant advancements in the ability to provide excellent care in a wide range of environmental and situational settings. Military medical personnel are trained and capable of providing care across the health continuum in support of disaster response, humanitarian relief, and contingency operations across the globe. While traditional military training platforms have served the military well in the past, an
opportunity exists to more effectively understand and apply individualized instructional design strategies to select, train, sustain, and remediate adult learners at all levels of the military medical health system. Non-military medical professionals have several, but not all, of the same issues as their military counterparts. Non-military medical professionals support disaster response and humanitarian relief, and take sabbaticals; depending on the duration of time away from their practice, they may encounter decay (or degradation) of some of their healthcare skills. Training strategies will need to be identified to effectively enhance an individual’s ability to assess, perform, and communicate medical response activities across a wide range of clinical,
operational, and environmental situations. The ability to effectively train individuals to care for patients will not only require a solid foundational knowledge but the ability to identify predictive markers (psychosocial, behavioral, etc.) that can be used to enhance the care and management of patients across the biopsychosocial model.
In many settings, the biopsychosocial training model is applied in a tiered approach. The foundation of this approach is built upon a solid understanding of anatomy and physiology, whereby the student is faced with correct and incorrect answers. As training progresses, students are required to apply critical thinking to align psychosocial issues with foundational knowledge in the development of differential diagnoses and management plans. The differential diagnosis and management plan, while founded in basic anatomy and physiology, is influenced by a wider variety of factors (some known and some unknown) in which the term “the art of medicine” comes into play. Many training programs utilize clinical immersion as a means to develop the “art of medicine” skill. Programs with longer training periods (i.e., MD, DO) typically result in individuals “self-selecting” their career track congruent with their ability and personal
preferences to perform within the biopsychosocial model. The same is not true for members of the healthcare team at entry-level training programs. Individuals in entry-level training programs are required to attain a wide range of foundational information and expected to integrate
psychosocial aspects often with limited immersive opportunities. The time and ability to effectively integrate aspects of the biopsychosocial model typically results in wide variation in applying the knowledge and skills in a variety of settings.
The DoD is already investigating opportunities to use Electronic Health Records (EHR) and psychomotor simulation task devices to detect skill decay and degradation. The intent of the current DoD research is to assess if an objective mathematical model, one that is yet to be
created, can be used to detect skill decay patterns for individual users. The assumption is that the development of these models would provide a means to deliver individually based sustainment and remediation to enhance overall clinical quality and patient safety. The application of these models may also benefit acquisition of knowledge and skills to tailor individualized learning. The application of these models should have broad availability, not only in content but also with the underlying architecture, by incorporating open source or open architectures that may inhibit systems communicating with other systems. While the intent is that these anticipated
mathematical models hold promise to monitor skill acquisition and decay, the question remains, what other markers (i.e., psychological, biometric, socio-economic, spiritual, sociologic, age, gender, and experience) may be leveraged to enhance training acquisition, sustainment and rehabilitation?
This FY16 announcement is requesting applications to identify markers that may be harnessed to effectively raise the ability, confidence, and proficiency of entry-level healthcare team members on the acquisition, sustainment, and remediation of skills. Are there individually based markers (i.e., personality types, learning strategies, experiences) associated with application of
knowledge to applied tasks? If markers do exist, are there means to modify instructional design settings to enhance or overcome learning barriers to “accelerate” this process? Do measurable markers exist (i.e., stress markers, cognitive testing, problem-solving strategies) that could be used to monitor an individual’s ability and capacity to learn new material? Do measurable markers exist that could be leveraged to create predictable metrics and evaluation criteria related to training objectives? Do markers exist that when present or absent have an effect on patient outcomes and well-being? Are there common behavioral, environmental, and observational markers that could be deconstructed to create predictable evaluation criteria and inserted into a skill acquisition, maintenance, or decay model that has yet to be created? Are there common and predictive markers that can be deconstructed to clearly discriminate healthcare providers defined as competent from those defined as proficient?
This announcement is seeking alternate predictive markers, aside from information from an EHR or from use of currently available simulation systems that assess psychomotor skills, that could be deconstructed into objective, or at least reliable, observational metrics and/or evaluation criteria that could eventually be inserted into computational models to select, train, sustain, and remediate healthcare professionals, initially at the entry-level healthcare team member.
Eventually the long-term goal is that there will be computational models that could possibly be applicable to all healthcare providers, at any experience level. These markers should be task / procedure / skill agnostic, if at all possible, but need to provide enough detail and specifics to demonstrate, through a domain-specific proof of concept, that the markers indeed show some level of predictability. A pilot test in an entry-level medical domain-specific area is needed as an outcome of this research, in addition to the research information and evidence-based
methodologies, to demonstrate feasibility of the skill acquisition, maintenance, or decay / degradation model. Linkage of data within the computational algorithms must also be demonstrated as a proof of concept.
B. Award Information
The FY16 JPC-1/MSIS Medical Decision Aids - Predictive Markers (SimMarkers) is seeking research that improves healthcare professionals’ cognitive and performance skill acquisition or
minimizes his/her skill decay. This research is seeking objective markers that could be inserted into a predictive model (one that has not been currently developed) to accurately and
appropriately assess a healthcare professional’s cognitive and performance status. These cognitive- and performance-type markers must be evidence-based and need to align with the respective credentialing or certifying healthcare organization. These cognitive- and
performance-type markers must also align with regional, local, and organization specific recommendations, guidelines, and standards, especially if they exceed the credentialing or certifying healthcare organization-specific recommendations, guidelines, and standards.
It is anticipated that this research will minimize the use of data / information using hospital EHR and will not concentrate on psychomotor skills; current work sponsored by the DHP is already underway in those areas.
It is anticipated that this research will uncover information that clearly delineates the cognitive training differences between training to competency versus training to proficiency as defined by Kirkpatrick*. It is anticipated that from this research there will be clear metrics / evaluation criteria that have been deconstructed that will discriminate between competency and proficiency. It is anticipated that from this research there will be common environmental and/or behavioral factors that can be deconstructed to form metrics / evaluation criteria that could be used as markers that will assist in the cognitive skill acquisition and minimization of skill decay. The research could employ resources, such as crowdsourcing, using evidence-based
methodologies, meta-analysis approaches, or other well-known evidence-based methodologies. A pilot study to test the markers is required. The pilot study may be in the medical domain at the discretion of the prospective Principal Investigator (PI) but should have significant applicability to military and government healthcare providers. Information about the pilot study needs to be incorporated in both the preproposal and full application. Items such as proposed
methodologies, type of recruits, recruitment numbers, anticipated drop-out rate, assessment criteria, inter-rater reliability, intended medical domain(s) (or discipline[s]), control groups, and statistical protocols are just a few of the anticipated items for incorporation in the full
application.
• The outcomes of research supported by the FY16 JPC-1/MSIS SimMarkers Project are as follows in no particular order:
○ A list of contact references and sources for the information that support the proposed markers, the anticipated methodologies proposed, and the methodologies to support the proposed pilot study;
○ A report, document, and/or list of the terminology and respective definitions used for the markers, proposed metrics / evaluation criteria, and to the chosen domain.
Terminology and definitions are needed for the environments, behaviors, characteristics, competency, proficiency, etc. should also be provided;
*
Kirkpatrick DL and Kirkpatrick JD. 2007. Implementing the Four Levels, Berrett-Koehler Publishers, San Francisco, California.
○ A report or document with the information and analyzed data of the actual postulated markers that best fits the meaning of medical decision aids that could be used to help identify skill acquisition or minimization of skill decay in healthcare personnel.
○ The pilot study analyzed data, study methodologies, recruitment size, inter-rater reliability, assessment criteria, results, conclusions, and potential next-step recommendations;
○ A video provided on compact disc (CD) that presents the proof of concept model using the markers that could be considered to effectively raise the ability, confidence and proficiency of healthcare team members on the acquisition, sustainment, and remediation of skills. Video reports must comply with the following specifications:
– Maximum run length: <= 6 minutes
– Audio codec: AAC
– Sample audio bit rate: 64 kbit/s (mono acceptable)
– Video codec: H.264
– Video resolution: <= 480 vertical lines
– Format: MPEG-4 (mp4) container
– Accepted formats: (mov, avi, mpg, mpeg, mp4, wmv)
– A fully vetted abstract and the intended publication for which results will be published
NOTE: This Program Announcement/Funding Opportunity is not about creating, developing, and analyzing patient surveys to evaluate medical professionals skills; this is not about
analyzing data / information using hospital EHR and will not concentrate on psychomotor skills acquisition or minimization of decay.
This Program Announcement/Funding Opportunity is not about developing a fully integrated healthcare provider cognitive skill acquisition or minimization of skill mathematical/
computational predictive model that could be inserted into a system. However, the selected markers, metrics, and evaluation criteria are intended to be used as information to be inserted into a proof of concept in order to conceptualize the utility of the chosen markers.
Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DoD-funded research involving new and ongoing research with human
anatomical substances, human subjects, or human cadavers must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), in addition to the local
Institutional Review Board (IRB) of record. Local IRB approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB. Allow a minimum of 2 to 3 months for HRPO regulatory review and
Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRMC ORP Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals. PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled “Research Involving Animals.” Allow at least 3 to 4 months for regulatory review and approval processes
for animal studies. Refer to Appendix 3 for additional information.
C. Eligibility Information
• Independent extramural investigators at all academic levels (or equivalent) are eligible to submit applications.
It is expected that the majority of work funded through this Program Announcement/Funding Opportunity will be performed within a DoD laboratory or medical treatment facility (MTF). Regardless of location, any work that is to be performed by associated non-DoD organizations must be limited to work performed under existing service contracts or under Cooperative Agreements or Material Transfer Agreements. The government reserves the right to administratively withdraw any application that does not meet these eligibility criteria. D. Funding
Submissions selected for funding will be processed for award by USAMRMC and awards made to organizations, not individuals. Awards to intramural organizations will be executed through the Military Interdepartmental Purchase Request (MIPR) or Funding Authorization Document (FAD) process. Transfer of funds is contingent upon appropriate safety and
administrative approvals. Intramural applicants and collaborators are reminded to coordinate receipt and commitment of funds through their respective resource managers.
• The maximum period of performance is 18 months.
• The anticipated total costs budgeted for the entire period of performance will not exceed $600,000. Associated indirect costs can be budgeted in accordance with the organization’s negotiated rate. No budget will be approved by the Government exceeding $600,000 total costs or using an indirect rate exceeding the organization’s negotiated rate.
• The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 18 months.
• Applicants must provide a detailed Federal Agency Financial Plan after the budget justification information in the Detailed Budget and Justification form. The plan must include the funding mechanism(s) and contractual arrangements that will be used to carry over funds between fiscal years, if applicable.
For this award mechanism, direct costs must be requested for:
• Travel costs for the PI(s) to an In-Progress Review (IPR) anticipated to be held near the end of the one year anniversary of the award or near end of the period of performance at a government location (to be determined). For planning purposes, it should be assumed that the meeting will be held in the National Capital Area/Maryland/Northern Virginia. These travel costs are in addition to those allowed for annual
scientific/technical meetings.
May be requested for (not all-inclusive):
• Salary, including contract personnel (Federal salaries paid by the parent organization may not be reimbursable)
• Research-related subject costs
• Support for multidisciplinary collaborations
• Equipment
• Research supplies
• Travel between collaborating organizations, including travel to military/Government facilities
• Travel costs to attend scientific/technical meetings in addition to the required IPR meeting described above
This Program Announcement/Funding Opportunity is intended for intramural investigators only. Extramural investigators are directed to apply through Grants.gov
(http://www.grants.gov/) under the Funding Opportunity Number W81XWH-15-DMR-MSIS-SIMMARKERS.
An intramural investigator is defined as a DoD military or civilian employee working within a DoD laboratory or MTF, or working in a DoD activity embedded within a civilian medical center. It is permissible for an extramural investigator to be named as a collaborator in an application submitted by an intramural investigator under this Program Announcement/Funding Opportunity. In such cases, the intramural organization will receive all funds and is
responsible for executing all necessary contractual or assistance funding awards to collaborating partners through their agency’s procedures.
The JPC-1/MSIS expects to allot approximately $2.4M of the FY16 DHP appropriation to fund approximately four intramural and/or extramural SimMarkers Project applications, depending on the quality and number of applications received from intramural and
extramural agencies and organizations. Funding of applications received in response to this Program Announcement/Funding Opportunity is contingent upon the availability of Federal funds for this program. NOTE: Applications received in response to both the SimMarkers intramural and extramural Program Announcements/Funding Opportunities will be evaluated and considered for funding together. The Government reserves the right to fund any combination of intramural and/or extramural applications.
II. SUBMISSION INFORMATION
Submission is a two-step process requiring both (1) pre-application submission and (2) application submission through the CDMRP eReceipt System (https://cdmrp.org/).
All submission dates and times are indicated on the title page of this Program Announcement/ Funding Opportunity. Pre-application and full application submissions are required. Failure to meet either of these deadlines will result in application rejection.
Start the submission process early. The CDMRP eReceipt System has a number of required steps that must be completed before submissions will be accepted. Be sure to allow adequate time for completion of all pre-application and application steps by their respective deadlines. A. Pre-Application Submission Content
All pre-application components must be submitted by the indicated deadline by the PI through the CDMRP eReceipt System (https://cdmrp.org/). Material submitted after the deadline, unless specifically requested by the government, will not be forwarded for processing.
PIs, collaborators, and organizations identified in the pre-application should be the same as those intended for the subsequent application submission. If any changes are necessary after
submission of the pre-application, the PI must contact the CDMRP Help Desk at [email protected] or 301-682-5507.
The pre-application consists of the following components, which are organized in the CDMRP eReceipt System by separate tabs:
• Application Information – Tab 1
○ Enter the application information as described in the CDMRP eReceipt System before continuing the pre-application.
• Application Contacts – Tab 2
○ Enter contact information for the PI responsible for the overall scientific and technical direction of this application and the organization’s Resource
Manager/Comptroller or equivalent personnel responsible for sponsored program administration. This contact information is required in the CDMRP eReceipt System. The pre-application will not be accepted without it. However, the CDMRP does not require approval of the pre-application by the PI’s organization.
• Collaborators and Conflicts of Interest (COIs) − Tab 3: To avoid COIs during
application screening and review processes, list the names of all scientific participants in the proposed research project, including co-investigators, mentors, collaborators, consultants, and subrecipients/subawardees. In addition, add all individuals outside of the application who may have a COI in the review of the application (including those with whom the PI has a personal or professional relationship) and choose “COI” from the drop-down list.
○ Pre-applications that designate a JPC-1 Medical Modeling, Simulation, and
Training Working Group member (listed in Appendix 4) as an investigator,
consultant, collaborator, or in a key personnel role will not be considered. For questions related to the JPC-1 Medical Modeling, Simulation, and Training Working Group members and pre-applications or applications, refer to Section IV.C., Withdrawal, or contact the CDMRP Help Desk at [email protected] or 301-682-5507.
• Required Files – Tab 4: Note: At this time, the CDMRP eReceipt System is unable to read files made with Adobe Acrobat PDFMaker version 9.0 and higher. The documents should conform to the formatting guidelines outlined in Appendix 1.
Preproposal Narrative (10-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings, etc.) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.
The Preproposal Narrative should include the following:
○ Problem to be Studied: Describe the perceived issue(s) and the problems to be studied. This section should serve as an abstract of the proposed work.
○ Theoretical Rationale, Scientific Methods, and Research: Describe how the research approach for accomplishing the specific aims is feasible, will accomplish the objectives, will provide information on proposed methods and analysis/ evaluation strategies, and is based on sound rationale. Clearly articulate how the proposed work and research are derived from evidence-based, best-of-class, well-documented, and/or well-adopted designs to best solve which markers, metrics, evaluation criteria will be determined in assessing healthcare provider cognitive skill acquisition or the minimization of skill decay.
‒ Background/Rationale: Clearly present the ideas and reasoning behind the proposed research. Include relevant literature citations, preliminary and/or pilot data, and/or other evidence that led to the development of the proposed
research. Any preliminary data should be from the laboratory of the PI or member(s) of the collaborating team.
‒ Hypothesis/Objective and Specific Aims: State the proposed project’s hypothesis and/or objectives and the specific aims/tasks of the proposed research.
‒ Approach/Methodology: Describe the research approach. Include research design, methods, and analysis/evaluation strategies as well as materials anticipated to be used during the research. If applicable, include a description of animal and/or human use in the proposed project. For studies involving animals and/or human subjects, include a description of the size, characteristics, and partnering organizations of the subject population that will be employed.
○ Significance, Relevance, and Innovation of the Proposed Effort:
‒ Significance and Relevance: Clearly articulate how the proposed research is relevant to the goal of developing methodologies that will support sustainment of cognitive processes that assist inpatient assessment, clinical reasoning, clinical judgment, and clinical diagnosis and treatment.
‒ Innovation: Explain how the proposed project is innovative and not an incremental advancement of previous work.
○ Proposed Study Design/Plan: Provide the intended research methodology that will support the pilot study. Provide preliminary information such as anticipated type of recruits, number of recruits, control group, anticipated assessment criteria, inter-rater reliability, and statistical protocols. Refer to Award Information, Section I.B., for additional information on the research areas of interest for this Program Announcement/Funding Opportunity.
○ Military Impact: Describe the anticipated short- and/or long-term outcomes of the proposed project and their potential impact on improving healthcare training and patient safety in the military health system. Refer to Award Information,
Section I.B., for additional information on the anticipated outcomes sought by this Program Announcement/Funding Opportunity.
○ Personnel and Facilities: Describe the role for the PI, co-PIs (if applicable), key personnel, sub-awards (if applicable), and consultants (if applicable) in the research team, including the expertise each brings to the proposed project. Explain how the team’s expertise is appropriate and complementary for achieving the research goals. Also, briefly provide information on the primary facility where the research is expected to be performed.
Pre-Application Supporting Documentation: Combine and upload the pre-application supporting documentation as a single PDF file. Items to be included as supporting documentation for the pre-application are limited to:
○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, title of reference, source of reference, volume, chapter, page numbers, and publisher, as appropriate).
○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative.
○ PI and Key Personnel Biographical Sketches (five-page limit per individual): Upload as “Biosketch_LastName.pdf.” – Bold or highlight publications relevant to the proposed project.
○ Budget Summary: Upload as “BudgetSummary.pdf.” – Complete the two-page Pre-Application Budget Summary Form (available for download in eReceipt at https://cdmrp.org/Program_Announcements_and_Forms) as instructed.
○ Quad Chart: Upload as “QuadChart.pdf.” – Provide a one-page Quad Chart that summarizes the proposed project. The format for the quad chart is available on the CDMRP eReceipt System at https://cdmrp.org/Program_Announcements_and_Forms.
• Submit – Tab 5: Enter your password in the space provided next to “Enter Your Password Here” and press the “Submit” button. Press the “Confirm Submission” button to complete the pre-application submission.
This tab MUST be completed for the pre-application to be accepted and processed by eReceipt.
• Other Documents Tab: This tab is not applicable during the pre-application submission process.
Pre-Application Screening
• Pre-Application Screening Criteria
All pre-applications received in response to this Program Announcement/Funding Opportunity and those received in response to the SimMarkers Extramural Program Announcement/Funding Opportunity will be screened by the JPC-1 Medical Modeling, Simulation, and Training Working Group members to determine technical merit and relevance to the mission of the DHP and JPC-1/MSIS. Pre-applications will be screened based on the following criteria, listed in descending order of importance:
○ Theoretical Rationale, Scientific Methods, and Research: To what degree the research approach for accomplishing the specific aims is feasible, will accomplish the objectives, will provide information on proposed methods and
analysis/evaluation strategies, and is based on sound rationale. To what degree the proposed work and research are derived from evidence-based, best-of-class, well-documented, and/or well-adopted designs to best solve how to formulate variables, metrics, and evaluation criteria will be determined in assessing healthcare provider (especially entry-level) cognitive skill acquisition or minimization of skill decay.
○ Significance, Relevance, and Innovation: To what degree the proposed research is relevant to the types of markers (such as competency vs. proficiency,
environmental, behavior) used to assess a healthcare provider’s (especially entry-level) skill acquisition and minimization of skill decay, especially with respect to patient safety, patient outcomes, and clinical outcomes. To what degree the
proposed work is innovative and novel, including whether the proposed research is duplicative of existing research.
○ Study Design/Plan: To what degree the proposed pilot study methodologies, anticipated type of recruits, number of recruits, control group, anticipated
assessment criteria, inter-rater reliability, and statistical protocols will justify and support the intended outcomes of the proposed research.
○ Military Impact: To what degree the project’s anticipated short- and/or long-term outcomes will impact the military and a future training program in healthcare delivery and patient safety in the military health system in a way that is consistent with the program’s goals.
○ Personnel and Facilities: To what degree the expertise, experience, and knowledge of the key research personnel (including co-PIs if applicable), sub-awards (if applicable), and consultants (if applicable) are appropriate and
complementary for achieving the research goals. To what degree the prime facility will be able to perform the proposed research.
• Notification of Pre-Application Screening Results
Following the pre-application screening, PIs will be notified as to whether or not they are invited to submit applications; however, they will not receive feedback (e.g., a critique of strengths and weaknesses) on their pre-application. The estimated timeframe for notification of invitation to submit an application is indicated on the title page of this Program Announcement/Funding Opportunity.
B. Full Application Submission Content
Applications will not be accepted unless the PI has received notification of invitation. All application components must be submitted by the indicated deadline by the PI through the CDMRP eReceipt System (https://cdmrp.org/). Material submitted after the deadline, unless specifically requested by the government, will not be forwarded for processing.
The application consists of the following components, which are organized in the CDMRP eReceipt System by separate tabs. To access these tabs, go to “My Applications” and click on “View/Edit Application Information” for the log number of the application that has been invited for submission.
• Application Information − Tab 1: This tab will be populated by eReceipt. Do not
change.
• Application Contacts − Tab 2: This tab will be populated by eReceipt. Do not
change.
• Collaborators and Conflicts of Interest (COIs) − Tab 3: This tab will be populated
by eReceipt. To avoid COIs during application screening and review processes, review and update (if needed) the names of all scientific participants in the proposed research project, including co-investigators, mentors, collaborators, consultants, and
subrecipients/subawardees. In addition, add all individuals outside of the application who may have a COI in the review of the application (including those with whom the PI has a personal or professional relationship) and choose “COI” from the drop-down list.
Applications that designate a JPC-1 Medical Modeling, Simulation, and Training Working Group member or advisor as an investigator, consultant, collaborator, or in a key personnel role will not be considered. A list of JPC-1/MSIS Working Group
members and advisors is included in Appendix 4.
• Required Files – Tab 4: Submit each component as an individual PDF file. Refer to Appendix 1, for detailed formatting guidelines. Note: At this time, the CDMRP eReceipt System is unable to read files made with Adobe Acrobat PDFMaker version 9.0 and higher.
Component 1: Project Narrative (20-page limit): Upload as
“ProjectNarrative.pdf.” The page limit of the Project Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings, etc.) used to describe the project. Inclusion of URLs that provide additional information to expand the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the application.
Describe the proposed project in detail using the outline below.
○ Background: Present the ideas and reasoning behind the proposed research; include relevant literature citations or preliminary data. Justify the rationale for the markers intended for investigation and how they will be able to discriminate healthcare providers as they are acquiring cognitive skills or how to minimize cognitive skills. Justification must also be provided as to how and why the intended markers will greatly benefit patients, through patient safety, patient outcomes, or clinical outcomes. Describe previous experience most pertinent to this project. Any preliminary data should be from the laboratory of the PI or member(s) of the
collaborating team.
‒ Clearly support the choice of study variables and explain the basis for the study questions and/or study hypotheses. Establish the relevance of the study and explain the applicability of the proposed findings.
○ Hypotheses/Objectives: State the hypotheses/study questions and overall objective(s) to be reached.
○ Specific Aims: Concisely explain the project’s specific aims. If this application is part of a larger study, present only tasks that this award would fund.
○ Study Design: Describe the experimental design, methods, and analyses/evaluations in sufficient detail for analysis.
‒ Identify and describe the hypothesis to be studied and the projected outcome of the proposed research.
‒ Define the pilot study variables and describe how they will be measured. Include a description of appropriate controls and the endpoints to be tested. Describe how data will be collected and analyzed in a manner that is consistent with the study objectives. Describe a plan for data access.
‒ Address any potential barriers and plans for addressing potential delays. Provide a risk management plan to address barriers to plans. As relevant, describe plans for addressing issues unique to working within the military health system.
‒ Document the availability and accessibility of the study materials (including data) needed as applicable.
○ Project Milestones: Identify timelines for critical events that must be
accomplished in order for the project to be successful in terms of cost, schedule, and performance.
○ Additional Information: If human and/or animal subjects are included in the research, applications may be submitted without human and/or animal use protocols and institutional approvals. However, protocols with required institutional
approvals must be submitted no later than 60 days after award to demonstrate continued progress and ensure continuation of payment. The Contracting or Grants Officer may make exceptions in situations where human and/or animal use is not expected to begin until after the first year of the research project. In such cases, a timeframe for submission of the appropriate protocols and institutional approvals will be established prior to award.
PIs and collaborating organizations may not use, employ, or subcontract for the use of any human participants, including the use of human anatomical
substances, human data, and/or human cadavers, or laboratory animals until applicable regulatory documents are approved by the USAMRMC to ensure that DoD regulations have been met.
‒ For studies with prospective accrual of human subjects, indicate quarterly enrollment targets.
‒ Identify cell line(s) and commercial or organizational source(s) to be used. If human anatomical substances (including cell lines) will be used, specify
whether or not identifiable information is accessible to the research team by any means.
‒ If applicable, indicate time required for submission and/or approval of documents (e.g., Investigational New Drug and Investigational Device Exemption) to the U.S. Food and Drug Administration or appropriate government agency.
‒ For studies involving human subjects, allow at least 2 to 3 months for regulatory review and approval by the USAMRMC HRPO; this does not include the additional time required for local IRB review and approval.
‒ For animal studies, allow at least 2 to 3 months for regulatory review and approval by the USAMRMC ACURO; this does not include the additional time required for local IACUC review and approval.
‒ Refer to Appendix 3 for additional regulatory information.
Component 2: Supporting Documentation. Start each document on a new page. Combine and upload as a single file named “Support.pdf.” If documents are scanned to pdf, the lowest resolution (100 to 150 dpi) should be used. There are no page limits for any of these components unless otherwise noted. Include only those components described below; inclusion of items not requested will result in the removal of those items or may result in administrative withdrawal of the application.
○ References Cited: List the references cited (including URLs if available) in the Project Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, title of reference, source of reference, volume, chapter, page numbers, and publisher, as appropriate).
○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms, and symbols.
○ Publications and/or Patent Abstracts: Include a list of relevant publication URLs and/or patent abstracts. If publications are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.
○ Facilities, Existing Equipment, and Other Resources: Describe the facilities and equipment available for performance of the proposed project and any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether or not Government-furnished facilities or equipment are proposed for use. If so, reference should be made to the original or present Government award under which the facilities or equipment items are now accountable. There is no form for this information.
○ Letters of Organizational Support: Provide a letter (or letters, if applicable) from the following:
‒ Resource Manager/Comptroller: Provide a letter of support from the applicant institution’s Resource Manager/Comptroller (or appropriate financial point of contact) assuring that the institution will be able to accept these funds, if
awarded. If funds are to be sent to multiple sites, include a letter from each site.
‒ Commander(s): Provide a letter(s) of support from appropriate Installation Commander or equivalent Commander/Director to ensure access to the facility, research population, and other necessary resources. The Commander should be aware of all submissions and should confirm that the proposed work is both feasible from a technical perspective and relevant from a programmatic and Command perspective.
○ Letters of Collaboration (if applicable): Provide a signed letter from each collaborating individual or organization that will demonstrate that the PI has the support or resources necessary for the proposed work. If the project involves collaboration with a Military Facility (military health system facility, research laboratory, treatment facility, dental treatment facility, or a DoD activity embedded with a civilian medical center), special requirements apply. A DoD researcher must obtain a letter from his/her commanding officer or Military Facility director authorizing his/her participation in the research project. This letter must be included with the application.
○ Intellectual Property
– Background and Proprietary Information: All software and data first produced under the award are subject to a Federal purpose license. Provide a list of all background intellectual property to be used in the project or provide a statement that none will be used. If applicable, state and identify the proprietary
information that will be provided to the Government and indicate whether the applicant will require a waiver of the Federal purpose license.
– Intellectual and Material Property Plan (if applicable): Provide a plan for resolving intellectual and material property issues among participating
organizations. Identify which potential components will be open source/open architecture versus proprietary in the proposed framework, design, and/or plan of a possible biopsychosocial training model and how the proposed model would integrate/communicate with other systems.
– Commercialization Strategy (if applicable): Describe the commercialization plan. The plan should include intellectual property, market size, financial analysis, strengths and weaknesses, barriers to the market, competitors, and management team. Discuss the significance of this development effort, when it can be anticipated, and the potential commercial use for the technology being developed.
○ Data and Research Resources Sharing Plan: Describe how data and resources generated during the performance of the project will be shared with the research community.
Component 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf.” Use only characters available on a standard QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed.
Abstracts of all funded applications may be publicly posted; therefore, proprietary information should not be included in the abstract.
The technical abstract should be clear and concise and, at a minimum, provide the following information:
○ Background: Provide a brief statement of the ideas and theoretical reasoning behind the proposed work.
○ Objective/Hypothesis: State the objective/hypothesis to be tested. Provide evidence or rationale that supports the objective/hypothesis.
○ Specific Aims: State concisely the specific aims of the study.
○ Study Design: Briefly describe the study design.
○ Impact: Provide a brief statement explaining the potential relevance of the
proposed work to improving patient safety and healthcare outcomes in the military health system and/or to the general public.
Component 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf.” Use only characters available on a standard QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed.
Not required at this time. Leave Attachment 4 space blank.
Component 5: Statement of Work (SOW) (two-page limit): Upload as “SOW.pdf.” The SOW outlines and establishes the PI’s and an organization’s performance expectations and timeline for the work to be funded under this award. A series of relatively short statements should be included that comprise the approach to each of the major goals or objectives of the proposed research. The statements should outline the specific tasks, systems, and materials that are reasonable estimates for testing
the proposed hypotheses of the study. An outline should be included that shows the work statements to be accomplished in each year of the award. If this application is part of a larger study, present only tasks that this award would fund. Allow at least 2 to 3 months for the USAMRMC Office of Research Protections’ regulatory review and approval processes for studies involving human subjects and 2 to 3 months for studies involving animal subjects.
Component 6: Outcomes and Impact Statement (one-page limit): Upload as “Impact.pdf.” Explain in detail why the proposed research project is important, as follows:
○ Describe the short-term impact: Describe the anticipated outcome(s)/results(s),
design, and/or plan that will be directly attributed to the results of the proposed research.
○ Describe the long-term impact: Describe the anticipated long-term gains from the
proposed research, including the long-term anticipated advantages that the new understanding may ultimately contribute. Articulate how the anticipated outcomes will contribute to providing the markers, metrics, evaluation criteria that could be inserted into a predictive model that then could be used to assess the healthcare provider cognitive skill acquisition and minimization of skill decay.
○ Military Relevance: Clearly articulate how the proposed research is relevant to the
goal of providing medical decision aids (markers, metrics, and evaluation criteria) that could be inserted into a predictive model that then could be used to assess the healthcare provider cognitive skill acquisition and minimize skill decay. State precisely the estimates as to the immediate and/or long-range usefulness of this study to the Armed Forces, as distinguished from general advancement of knowledge in medicine.
○ Public Purpose: Provide a concise, detailed description on how this research
project will benefit the general public.
Component 7: Innovation Statement (two-page limit): Upload as “Innovation.pdf.” Describe how the proposed project is innovative. Research deemed innovative may introduce a new paradigm, challenge current paradigms, look at existing problems from new perspectives, or exhibit other creative qualities. Investigating the next logical step or incremental advancement on published data is not considered innovative. This may include a proposed conceptual framework, design, and/or plan of key components and how they integrate/communicate with each other.
Component 8: Biographical Sketches: Combine biographical sketches and current/pending support documentation for the PI and all key personnel into a single PDF file and upload as “Biosketches.pdf.”
○ The suggested biographical sketch format is available on the “Program Announcement and Forms” page in the CDMRP eReceipt System
(https://cdmrp.org/Program_Announcements_and_Forms/). Use of this document is optional.
○ Current/Pending Support: For all current and pending research support, include the title, time commitments, supporting agency, name and address of the funding agency’s procuring Contracting/Grants Officer, performance period, level of funding, brief description of the project’s goals, and list of the specific aims. If applicable, identify where the proposed project overlaps with other current and pending research projects. Clearly state if there is no overlap. If there is no current or pending support, enter “None.” An updated current and pending support
document will be required during award negotiations
Component 9: Budget and Budget Justification: Use the Detailed Budget and Justification form available on the “Program Announcement and Forms” page in the CDMRP eReceipt System (https://cdmrp.org/Program_Announcements_and_Forms/). Upload as “Budget.pdf.”
Submit a detailed budget and budget justification that cover the entire period of performance (not just the first year). All costs must be entered in U.S. dollars. The budget and budget justification must be sufficiently detailed so that the government can determine the proposed costs to be allowable, allocable, and reasonable for the
proposed research. The government reserves the right to request a revised budget and budget justification and/or additional information.
Budget Instructions: Complete the Detailed Budget and Justification form. Begin by entering the PI name, CDMRP log number, and period of performance fields at the top of page F-1 of the Detailed Budget and Justification form. Following the guidelines below, enter the required information under “Detailed Budget for Year One” on pages F-1 (Senior/Key Person and Other Personnel) and F-2 (Other Direct Costs). Clearly justify each budget item for the entire period of performance in the Justification section on page F-4.
○ Senior/Key Person and Other Personnel: Personnel involved in the project should be listed in this section; however, this award is not intended to provide salary support for any federal employee, as those costs were to have been included in infrastructure costs previously provided. If salary support is requested, sufficient justification must be provided in the budget justification section.
– Name: Beginning with the PI, list all participants who will be involved in the project during the initial budget period, whether or not salaries are requested. Include all collaborating investigators, research associates, individuals in training, and support staff.
– Role on Project: Identify the role of each participant listed. Describe his/her specific functions in the budget justification.
– Type of Appointment (Months): List the number of months per year reflected in an individual’s contractual appointment with the applicant organization. The government assumes that appointments at the applicant organization are full time for each individual. If an appointment is less than full time (e.g., 50%), note this with an asterisk (*) and provide a full explanation in the budget justification. Individuals may have split appointments (e.g., for an academic
period and a summer period). For each type of appointment, identify and enter the number of months on separate lines.
– Annual Base Salary: Enter the annual organizational base salary (based on a full-time appointment) for each individual listed for the project.
– Effort on Project: List the percentage of each appointment to be spent on this project for all staff members including unpaid personnel.
– Salary Requested: Enter the salary for each position for which funds are requested. This is calculated automatically from the data provided. If you do not wish this to be calculated for you, uncheck the small “Calculate Salary” checkbox in the bottom of the field. Calculate the salary request by multiplying an individual’s organizational base salary by the percentage of effort on the project.
– Fringe Benefits: Enter the fringe benefits requested for each individual in accordance with organizational guidelines.
– Totals: Calculated automatically from the data provided.
○ Other Direct Costs: Itemize and clearly justify all additional direct costs as components of the budget categories listed below. Enter the itemized budget information for the first year on page F-2.
○ Equipment: Provide an itemized list of proposed equipment, showing the cost of each item. Equipment is any article of nonexpendable tangible property having a useful life of more than 1 year and an acquisition cost of $5,000 or more per unit.
○ Travel Costs: Travel costs may include:
– Required attendance at one 1-day IPR meeting, to be held in the National Capital Region.
– Attendance at scientific/technical meetings. Include the meeting name, purpose, location, and date, if known, in the budget justification.
– Travel associated with the execution of the proposed work (if applicable). Reasonable costs for travel between collaborating organizations should be included and are not subject to the yearly cost limitation on travel to scientific/ technical meetings. International travel may be requested but must be well justified, requested no less than 180 days before travel, and is subject to approval by the CDMRP.
○ Materials, Supplies, and Consumables: The budget justification for supporting material and supply (consumable) costs should include a general description of expendable material and supplies. If animals are to be purchased, state the species, strain (if applicable), number to be used, cost per animal, and proposed vendor. If human cell lines are to be purchased, state the source, cost, and description.
○ Consultant Costs: Regardless of whether funds are requested, include in the budget justification the names and organizational affiliations of all consultants, and include the daily consultant fee, travel expenses, nature of the consulting effort, and why consultants are required for the proposed research project.
○ Partnership/Collaboration Costs: Should an extramural organization propose collaboration with an intramural entity for part of the research effort, the intramural organization will receive all funds and is responsible for executing all necessary contractual or assistance funding awards to collaborating partners through their agency’s procedures. All direct and indirect costs of any partnership/collaboration costs must be included in the total direct costs of the primary award. The nature of the partnership/collaboration should be described in the Budget Justification section.
○ Research-Related Subject Costs: Include itemized costs of subject participation in the proposed research. These costs are strictly limited to expenses specifically associated with the proposed research.
○ Other Expenses: Itemize other anticipated direct costs such as publication and report costs, equipment rental (provide hours and rates), communication costs, and organizationally provided services. Unusual or expensive items should be fully explained and justified. Estimate the costs of publishing and reporting research results, including direct charges for clerical preparation, illustrations, reprints, and distribution. Organizationally provided services should be supported by the
organization’s current cost/rate schedule. These items should be described in detail and clearly justified.
○ Total Direct Costs: Calculated automatically from the data provided for the initial budget period on page F-2 and for the entire proposed period of support on
page F-3.
○ Total Indirect Costs: This award is not intended to provide funds for indirect costs to the applicant organization. All direct and indirect costs of any proposed collaborator must be included in the total direct costs of the primary award. If funds for indirect costs are requested, sufficient justification must be provided in the budget justification section. The government reserves the right to disallow any indirect costs not sufficiently justified.
○ Total Costs: This section is calculated automatically from the data provided.
○ Fee: A profit or fixed fee is not allowable on awards or on subawards.
Budget Justification Instructions: Provide a clear budget justification for each item in the budget over the entire period of performance in the Justification section (page F-4) of the Detailed Budget and Justification form.
○ Federal Agency Financial Plan (required): Provide a detailed Federal Agency Financial Plan after the budget justification information in the Detailed Budget and Justification form. Applications must provide a plan delineating how all funds (FY16) will be obligated by September 30, 2017. The plan must include the funding mechanism(s) or contractual arrangements that will be used to carry over funds between fiscal years, if applicable.
○ PIs must plan to have 90% of FY16 funds disbursed and/or obligated by
September 30, 2016. Any funding not obligated by September 30, 2017 may be withdrawn by the issuing Comptroller.
• Submit – Tab 5: Once all components have been uploaded, enter your password in the space provided next to “Enter Your Password Here” and press the “Submit” button. Press the “Confirm Submission” button to complete the application submission. This tab MUST be completed for the application to be accepted and processed by eReceipt.
• Other Documents Tab: This tab is not applicable during the application submission process.
III. APPLICATION REVIEW INFORMATION A. Application Review and Selection Process
All applicants are evaluated by scientists, clinicians, and consumer advocates using a two-tier review process. The first tier is peer review of applications against established criteria for determining technical merit. The second tier is a programmatic review that makes
recommendations for funding to the DHA RDA Directorate and the Office of the Assistant Secretary of Defense for Health Affairs, based on (a) technical merit and (b) the relevance to the mission of the DHP and JPC-1/MSIS and to the specific intent of the award mechanism. The highest-scoring applications from the first tier of review are not automatically recommended for funding. Additional information about the two-tier process used by the CDMRP can be found at http://cdmrp.army.mil/about/fundingprocess.shtml.
All CDMRP review processes are conducted confidentially to maintain the integrity of the merit-based selection process. Panel members sign a nondisclosure statement that application and evaluation information will not be disclosed outside the panel. Violations of confidentiality can result in the dissolving of a panel(s) and other corrective actions. In addition, personnel at the applicant or collaborating organizations are prohibited from contacting persons involved in the review process to gain protected evaluation information or to influence the evaluation process. Violations of these prohibitions will result in the administrative withdrawal of the organization’s application. Violations by panel members or applicants that compromise the confidentiality of the review process may also result in suspension or debarment from Federal awards.
Furthermore, the unauthorized disclosure of confidential information of one party to another third party is a crime in accordance with Title 18 United States Code 1905.
B. Application Review Process
1. Peer Review: To determine technical merit, all applications will be evaluated according to the following scored criteria, which are listed in decreasing order of importance:
• Theoretical Rationale and Scientific Methods
○ To what degree the research approach for accomplishing the specific aims are feasible, will accomplish the objectives, will provide information on proposed methods and analysis/evaluation strategies, and is based on sound rationale. To what degree the proposed work and research is derived from evidence-based, best-of-class, well-documented, and/or well-adopted designs to best solve which
markers, metrics, evaluation criteria will be determined in assessing healthcare provider (especially entry-level) cognitive skill acquisition or minimization of skill decay.
○ To what degree the proposed research is relevant to the types of markers (such as competency vs. proficiency, environmental, behavior) used to assess a healthcare provider’s (especially entry-level) skill acquisition and minimization of skill decay, especially with respect to patient safety, patient outcomes, and clinical outcomes.
○ How well the study aims, hypotheses or objectives, experimental design, methods, and analyses are designed to clearly answer the research questions.
○ Whether the proposed research and work provide a listing of evidence-based definitions, nomenclature, or lexicon that supports the proposed methodologies on determining which markers, metrics, and evaluation criteria should be investigated and why.
○ How well the proposed methodologies, type of recruits, recruitment numbers, anticipated drop-out rate, assessment criteria, inter-rater reliability, intended medical domain(s) (or discipline[s]), control groups, statistical protocols, etc., supporting the pilot-study are presented and aligned with the proposed study outcomes.
○ Whether there is evidence of an adequate contingency plan, such as a risk mitigation plan, to resolve potential delays.
• Relevance, Innovation, and Impact:
○ How the proposed research is relevant to the goal of incorporating evidence-based methodologies and techniques and how and why the proposed markers, metrics, and evaluation criteria are relevant and impactful to patient safety, patient outcomes, and clinical outcomes while also novel and innovative ways to potentially track how healthcare provider cognitive skills are acquired and skill decay is minimized.
○ How the proposed work is innovative and novel, including whether the proposed research is duplicative of existing research.
○ To what degree the proposed research, domain, and pilot study are relevant to the goal of this announcement.
○ To what degree the proposed markers, metrics, and evaluation criteria are relevant compared to healthcare facilities other than the PI’s organization. Are the proposed markers, metrics, and evaluation criteria locally applicable or do they have broader applications?
○ To what degree the anticipated short- and long-term outcomes resulting from the proposed study will contribute to the goal of improving patient safety and healthcare outcomes.
• Personnel and Facilities:
○ How the composition and balance of the research team (including other organization personnel, sub-awards, and consultants, as applicable) are appropriate.
○ To what degree the PI’s and research team’s backgrounds and expertise are appropriate and complementary to accomplishing the proposed work.
○ To what degree the levels of effort by the PI and other key personnel are appropriate to ensuring the success of proposed research.
○ To what degree the research environment and the accessibility of institutional resources support the proposed study (including collaborative arrangements).
○ Whether there is evidence for appropriate institutional commitment.
In addition, the following unscored criteria will also contribute to the overall evaluation of the application:
• Budget
○ Whether the budget is appropriate for the proposed research and within the limitations of this Program Announcement/Funding Opportunity.
○ Whether the proposed timeline is appropriate and tasks outlined in the application are logical in their progression.
• Intellectual Property and Commercialization Plan
○ If applicable, to what degree the intellectual property plan is appropriate.
○ If applicable, to what degree the commercialization plan is appropriate.
• Application Presentation
○ To what extent the writing, clarity, and presentation of the application components influence the review.
2. Programmatic Review: To make funding recommendations and select the application(s) that, individually or collectively, will best achieve the program objectives, the following criteria are used by programmatic reviewers:
a. Ratings and evaluations of the peer reviewers
b. Relevance to the mission of the DHP and JPC-1/MSIS, as evidenced by the following:
• Adherence to the intent of the award mechanism
• Programmatic relevance & portfolio balance
• Relative impact, innovation, and novelty
• Degree of public accessibility of outcomes
